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Ecotoxicological information

Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
96 hour
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Taken from Australian NICNAS report reviewing class of substance confirms that fish is typically no more sensitive than algea or Daphnia and further animal testing is not justified.
The sulphated betaine substance in this summary was selected for read-across as it contains the same betaine group considered responsible for the main toxicological effects on aquatic organisms. The additional sulphate group will reduce surface tension further than the carboxylate group that is present in the substance to be registered.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
not specified
Remarks:
No details given in the publication
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
other: Review covering three species
Details on test organisms:
Different species; Zebra Fish, Red Killifish, Rainbow Trout
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not specified
Hardness:
Within guidelines
Test temperature:
Within guidelines
pH:
Within guidelines
Dissolved oxygen:
Within guidelines
Nominal and measured concentrations:
Not specified
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 2.6 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: Rainbow trout
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 9.2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: Red killifish
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 36.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: Zebra fish
Details on results:
Zebra fish, LC50 ≥ 36.8 mg/L; Red killifish, LC50 ≥ 9.2 mg/L;Rainbow trout, LC50 ≥ 2.6 mg/L.For the purposes of classification, the minimum median lethal concentration of the most sensitive fish species (rainbow trout 96 h EC50 = 2.6 mg/L
Validity criteria fulfilled:
not specified
Conclusions:
The review document did not provide great detail of the testing, but the data were considered valid by the assessors working under Australian NICNAS. The headline result for rainbow trout was approximatley as sensitive as to Daphnia and algea in this review and for the other two species, fish appear more tolerant than the other types of organism. The sulphated betaine substance in this summary was selected for read-across as it contains the same betaine group considered responsible for the main toxicological effects on aquatic organisms.
In conclusion, it is not considered warranted to perform additional testing on vertebrates.
Executive summary:

The read-across to the sulphated betain is considered justified as the phosphate ester is considered likely to partly hydrolyse to form products that include phosphated betaines. The sulphate will have similar surface active properties and indeed, appears ot have similar effects to Daphnia.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
96 hours
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
US EPA Published
Primary source not known
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Methods not fully described
GLP compliance:
not specified
Specific details on test material used for the study:
Source not specified
Analytical monitoring:
not specified
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 2 mg/L
Conc. based on:
act. ingr.
Remarks:
reported for substance
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Conclusions:
Fish appear to be less sensitive than algae to this class of substance.
Further testing is not justified.

Description of key information

The read-across to these other betaine species is considered justified. The Cosmetic Ingredient Review Expert Panel reviewed the product use, formulation and safety data of eleven alkyl betaines, as used in cosmetics. (Final report issued 2014-04-04). The Panel concluded that the common core chemical structure, similar functions and concentrations in cosmetics, and the predicted physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group

Evidence shows that fish are more tolerant to the class of substance than algae and further animal testing is not justified

Acute toxicity is predicted to be in the range of 1 - 10 mg/l. The value chosen here is the lowest value from the published data on various fish species.

Key value for chemical safety assessment

LC50 for freshwater fish:
2 mg/L

Additional information